Controllable endoscopic sheath apparatus and related method of use

ABSTRACT

A controllable sheath for optimizing the control of surgical instruments at the operation site includes a flexible sheath surrounding an endoscope and including a lumen extending along the walls of the sheath and adjacent to the endoscope. The lumen permits the passage of surgical instruments from the proximal end of the endoscopic device to the operation site. The lumen extends beyond the distal end of the endoscope and deflects at the distal end as desired by the operator&#39;s manipulation of a controller device. This distal end deflection may occur through various different techniques where the ability to deflect the lumen gives the operator increased control and maneuverability over the surgical implements located in the lumen. Depending upon the particular requirements of the surgical procedure, the controllable sheath may include any number of lumens capable of distal end deflection.

BACKGROUND OF THE INVENTION

[0001] 1. Field of the Invention

[0002] The present invention relates to endoscopic devices, and, moreparticularly, to a sheath, external to an endoscope, that includesworking channels capable of controllable deflection at their distalends, and to a related method of using the sheath during an endoscopicoperation.

[0003] 2. Background of the Related Art

[0004] An endoscope is a flexible medical device for insertion into abody passageway or cavity that enables an operator, positioned at aremote external location, to perform certain surgical procedures at asite internal to the patient's body. In general, an endoscope includes along flexible tubular member equipped with, for example, a miniatureviewing device, an illumination device, and working channels. Theendoscope has a proximal end that remains external to the patient and adistal end having an endoscope tip for insertion into a body cavity ofthe patient.

[0005] A typical endoscope 10 is illustrated in FIG. 1. An illuminationdevice of endoscope 10 typically includes a lens 16 at an endoscope tip14. Lens 16 is positioned proximate to a viewing device 17. Lightemanates from lens 16 to enable viewing device 17 to capture images inthe body cavity and electrically or optically transmit the imagesthrough a tubular body 13 of endoscope 10 for display at an externalmonitor. Once viewing the transmitted images, the endoscope operator mayinsert one or more surgical instruments through working channels 18, 20to perform an endoscopic procedure at the internal body cavity site.These endoscopic procedures may include, for example, snare resections,injections, or biopsies of particular internal areas of the patient'sbody.

[0006] Often, these endoscopic procedures require the use of multipleendoscopic instruments working in cooperation, where each instrumentinserts through a separate working channel. Because these instrumentswork in cooperation, their maneuverability at the endoscope tip iscritical to the success of the surgical procedure. But, thismaneuverability is limited by the diameter constraints of the endoscopetip which, in turn, are dictated by the particular body cavitydimensions of the patient. Endoscope designs have evolved to minimizethe diameter of the endoscope tip to limit the discomfort experienced bythe patient. These designs, however, have failed to maximize themaneuverability of therapeutic devices at the endoscope tip. Forexample, the working channel of the conventional endoscope remainscoexistent with the endoscope and offers no independent motion inrelation to the endoscope. Such a limitation impedes the maneuverabilityof surgical instruments at the operation site since they are constrainedto follow the movement of the endoscope.

[0007] With reference once again to FIG. 1, working channels 18, 20 ofendoscope 10 are located internal to endoscope 10, positioned in closeproximity to one another, and fixed in the endoscope with no independentmobility. In essence, working channels 18, 20 simply provide a passagefor the surgical instruments to reach endoscope tip 14. Because workingchannels 18, 20 are fixed and located in such close proximity to oneanother, the endoscope operator has limited range of motion over thesurgical instruments at the operation site. This limited mobility notonly hinders the cooperation between the multiple surgical instrumentsbut also inhibits the potential for advancement into more complexendoscopic procedures.

[0008] Consequently, there is a need for an endoscopic device withworking channels that, in addition to providing a passage for thesurgical instruments, optimizes the mobility of the surgical instrumentsat the operation site, while maintaining the required dimensionalconstraints to permit travel of the endoscopic device through the bodycavities of the patient.

SUMMARY OF THE INVENTION

[0009] The advantages and purpose of the invention will be set forth inpart in the description which follows, and in part will be obvious fromthe description, or may be learned by practice of the invention. Theadvantages and purpose of the invention will be realized and attained bymeans of the elements and combinations particularly pointed out in theappended claims.

[0010] To attain the advantages and in accordance with the presentinvention, as embodied and broadly described herein, the controllableendoscopic sheath of the present invention includes a flexible elongatedsheath for surrounding an endoscope. The flexible sheath contains aflexible working lumen extending within the sheath and adjacent to theendoscope so as to permit the lumen to move in relation to the endoscopeand beyond a distal tip of the endoscope. The flexible working lumenincludes a deflectable distal end. The endoscopic sheath also includes acontroller device connected to the distal end of the lumen forcontrolling deflection of the distal end of the lumen.

[0011] According to an aspect of the invention, the controller deviceincludes a wire member disposed on the lumen. The wire member possessesa naturally deflected state as well as an elastic memory and returns toits deflected elastic memory once the wire member extends beyond adistal tip of the endoscope. The distal end of the lumen deflects inresponse to the distal end deflection of the wire member.

[0012] In another aspect, the controller device includes a stiffeningmember disposed alongside the outside of the lumen and adjacent to theendoscope. The lumen further includes a deflectable lumen tip having anaturally deflected state and an elastic memory. The material of thestiffening member possesses sufficient rigidity to impede only theelastic memory of the lumen tip. The lumen tip, once extended beyond thestiffening member, returns to its original deflected position, thus,causing the distal end of the lumen to deflect.

[0013] In still another aspect of the invention, the controller deviceincludes a flexible extension disposed on the lumen at a distal end. Theflexible extension attaches to a flexible elongated member that extendsalong the lumen from the proximal to the distal end of the lumen. Theelongated member eccentrically attaches to the flexible extension. Theproximal pulling of the elongated member shortens the correspondinglength of the elongated member eccentrically attached to the flexibleextension and causes the flexible extension to deflect. In response tothis deflection, the distal end of the lumen deflects.

[0014] The method for using the controllable endoscopic sheath of thepresent invention in an endoscopic procedure includes inserting anendoscopic device into a body cavity, the endoscopic device having anendoscope, a flexible elongated sheath surrounding the endoscope, and aflexible lumen extending with the sheath and adjacent to the endoscopefor containing a surgical tool. Maneuvering the endoscopic devicethrough the body cavity and proximate to an operation site. Oncearriving proximate to the operation site, extending a distal end of thelumen beyond a distal tip of the endoscope. And deflecting the extendeddistal end of the lumen to maneuver the surgical tool. According to anaspect of the invention, the endoscopic device further includes a wiremember having a naturally deflected state as well as an elastic memoryand disposed adjacent to the lumen. For such an endoscopic device, thedeflecting step includes extending the wire member beyond the distal tipof the endoscope.

[0015] In another aspect, the endoscopic device includes a lumen havinga naturally deflected state and elastic memory at the distal end. Forsuch an endoscopic device, the deflecting step includes extending astiffening member beyond the distal tip of the endoscope, where thestiffening member impedes the distal end of the lumen from retaining itsnaturally defected state.

[0016] In still another aspect of the invention, the endoscopic deviceincludes an elongated member disposed on the lumen and eccentricallyattached to a flexible extension. The elongated member extends from aproximal end of the lumen to a point proximate the distal end of thelumen and the flexible extension resides at the distal end of the lumen.For such an endoscopic device, the deflecting step includes retractingthe elongated member from the proximal end to shorten the distal end ofthe elongated member and deflect the flexible extension.

[0017] Additional advantages of the invention will be set forth in partin the description which follows, and in part will be obvious from thedescription, or may be learned by practice of the invention. Theadvantages of the invention will be realized and attained by means ofthe elements and combinations particularly pointed out in the appendedclaims.

[0018] It is to be understood that both the foregoing generaldescription and the following detailed description are exemplary andexplanatory only and are not restrictive of the invention, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The accompanying drawings, which are incorporated in andconstitute a part of this specification, illustrate several embodimentsof the invention and together with the description, serve to explain theprinciples of the invention. In the drawings,

[0020]FIG. 1 is a fragmentary perspective view of a conventionalendoscope;

[0021]FIG. 2 is a fragmented perspective view of a preferred embodimentof a controllable endoscopic sheath according to the present invention;

[0022]FIG. 3 is a cross-sectional view on line II-II of FIG. 2;

[0023]FIG. 4 is a fragmented perspective view of a second preferredembodiment of a controllable endoscopic sheath according to the presentinvention;

[0024]FIG. 5 is a cross-sectional view on line IV-IV of FIG. 4;

[0025]FIG. 6 is a cross-sectional view similar to FIG. 5, but showing avariation of the second embodiment;

[0026]FIG. 6A is an exploded cross-sectional view of region A of FIG. 6;

[0027]FIG. 7 is a fragmented perspective view of a third preferredembodiment of a controllable endoscopic sheath according to the presentinvention;

[0028]FIG. 8 is a cross-sectional view on line VII-VII of FIG. 7;

[0029]FIG. 9 is a cross-sectional view on line VIII-VIII of FIG. 7;

[0030]FIG. 10 is a fragmented perspective view of the third preferredembodiment showing the extension of lumens beyond an endoscopic distaltip;

[0031]FIG. 11 is a cross-sectional view on line X-X of FIG. 10;

[0032]FIG. 12 is a cross-sectional view on line X-X of FIG. 10 showingthe distal end deflection of the lumens;

[0033]FIG. 13 is a side view of a spherical mating member asincorporated in the third preferred embodiment of a controllableendoscopic sheath according to the present invention;

[0034]FIG. 14. is an end view of a female receiving end of the sphericalmating member of FIG. 13; and

[0035]FIG. 15. is an end view of a male end of the spherical matingmember of FIG. 13.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0036] Reference will now be made in detail to the present preferredembodiments of the invention, examples of which are illustrated in theaccompanying drawings. Wherever possible, the same reference numberswill be used throughout the drawings to refer to the same or like parts.

[0037] The present invention is directed towards a controllable sheathfor use with an endoscope. The sheath surrounds the endoscope and has adeflectable distal end. The sheath further includes at least one lumen,and preferably a plurality of lumens, extending within the sheath andalong the outside of the endoscope. During an operation at a surgicalsite, endoscopic instruments insert into the lumens to perform asurgical operation. Since the lumens are located along the outside ofthe endoscope, working channels internal to the endoscope can beeliminated to decrease the diameter of the endoscope. By positioning thelumens along the endoscope exterior, the overall cross-sectionaldimension of the endoscopic device may be decreased, thus, optimizingthe maneuverability of the endoscopic device through the operativechannels of the patient.

[0038] The distal end of the lumens, according to the present invention,may be controlled to extend beyond the endoscope tip and deflect by acontroller device. The controller device connects to the distal end ofthe lumen and controls the distal end deflection of the lumen. As such,the sheath optimizes the mobility of the entire device, including theendoscope, through the operative channels. The lumens also increase themaneuverability of the surgical instruments at the operation site bypermitting the distal end of the instruments to be directed more closelyto the site and move independently with respect to one another in amyriad of directions. To permit this enhanced maneuverability, the lumenis preferably constructed of a flexible plastic material, such asteflon, polypropylene, polytetrafluoroethylene, tetrafluoroethylene, ornylon.

[0039] In a preferred embodiment of the present invention, as shown inFIGS. 2 and 3, a controllable endoscopic sheath 28 encloses an endoscope30. Sheath 28 includes lumens 32, 34 extending from a proximal end 36that exists external to endoscope 30 to a distal end 38. Sheath 28 alsoincludes a central covering 29 that extends over the perimeter ofendoscope 30 and is integral with slots 31 that cover lumens 32, 34.Coverings 29 and 31 and lumens 32, 34 are preferably made of a materialsuitable for insertion into a human body.

[0040] Not shown in the FIGS. 2 and 3 are many of the details of theproximal end of the complete endoscopic device, which includes endoscope30 and sheath 28. For example, the proximal end of the endoscopic deviceincludes a conventional endoscope proximal handle and is configured toreceive the sheath of the present invention.

[0041] Lumens 32, 34 provide channels for the insertion of surgicalinstruments. The operator may control the movement of the surgicalinstruments at the distal end or operation site by manipulating acontrolling device to be described. The controlled movement of thesurgical instruments results from the controlled distal end deflectionof the walls of the lumen.

[0042] The ability to deflect distal end 38 of the walls of lumen 32, 34gives the operator increased control over the surgical instruments atthe working area. Lumen 32, 34 is generally designed to accommodatemedical instruments and are disposed at various locations about theperimeter of endoscope 30. Although the preferred embodiment shown inFIG. 2 includes two lumens 32, 34, it is to be understood that acontrollable endoscopic sheath according to the present invention mayinclude any number of lumens positioned around the perimeter of theendoscope. Preferably, the lumens are equally spaced about endoscope 30to give the operator the greatest range of motion at the working area.For example, as depicted in FIG. 2, lumens 32, 34 are placed on opposingsides of the endoscope perimeter.

[0043] During insertion of the entire endoscopic device (endoscope 30and sheath 28 including lumens 32, 34) into a patient, distal end 38 ofthe endoscopic device is generally flat. In other words, the distal endsof endoscope 30, and sheath 28, and its lumen 32, 34 terminate atsubstantially the same plane to enable the endoscopic device to navigatethroughout the contours of the body cavity without causing unnecessarypain and discomfort to the patient. Although the insertion of theendoscopic device with one or more lumens 32, 34 extended is possible,it is not preferred because the extended lumens 32, 34 may block thevisibility of viewing device 27 of endoscope 30 or collide with the sidewalls of the body cavity.

[0044] Once distal end 38 of the endoscopic device arrives at thedesired surgical site, lumens 32, 34 are extended beyond endoscope tip40 as desired by the operator. Although the lumens may extendsimultaneously, preferably each lumen extends independently to offer theendoscope operator enhanced distal end control at the surgical site. Asmentioned earlier, to permit the desired extension of lumens 32, 34beyond endoscope tip 40, each lumen 32, 34 resides within a slot 31 ofsheath 28, as best shown in FIG. 3. To aid in the movement of lumens 32,34, the exterior surfaces of lumens 32, 34 and/or the interior surfacesof slots 31 preferably possess a lubricious coating or resin, stitch asteflon, polypropylene, or nylon. To move lumen 32, 34 with respect toendoscope tip 40, the operator advances or retracts lumen 32, 34 at theproximal end. This proximal end manipulation causes lumen 32,34 to movewithin slots 31 of sheath 28. For example, to advance the distal end ofa particular lumen 32, 34 beyond endoscope tip 40, the operator pushesthe proximal end of the lumen 32, 34 towards the surgical site asdesired. To retract the lumen 32, 34 from endoscope tip 40, the reverseprocedure is implemented. Specific arrangements to advance and retractlumen 32, 34, and cause their deflection at the distal end, will bedescribed herein.

[0045] By extending lumen 32, 34 beyond endoscope tip 40 and controllingits distal end deflection, the endoscope operator may manipulate theposition of the surgical instruments at the operation site in a myriadof ways. This increased mobility and control optimizes the coverage areaof the surgical instrument because lumens 32, 34 may extend beyondendoscope tip 40 and deflect in any direction desired by the operator.Further, the distal end extension of lumen 32, 34 beyond endoscope tip40 provides the operator with enhanced control over the surgicalinstruments and the operation because lumen 32, 34 may transport thesurgical instruments more closely to the operation site. For example, incertain cavities of the body, the contours of the operative channel maybe such that the endoscopic device cannot traverse the operativechannel. In such situations, the extension and control of lumen 32, 34beyond endoscope tip 40 of endoscope 30. enables the operator to performthe surgical procedure in areas previously .unreachable by conventionalendoscopes.

[0046] The deflection of lumen 32, 34 at distal end 38 also allows forthe interaction and communication between multiple surgical instruments.For example, one instrument may grasp and manipulate an object withinthe body cavity while the other instrument may perform the desiredprocedure. Since lumens 32, 34 are preferably dispersed on opposing endsof endoscope 30. the surgical instruments may communicate with eachother at various angles previously unattainable using conventionalendoscopes.

[0047] The present invention includes a device to control the deflectionof the distal end of lumen 32, 34. The controller device, or actuator,according to a preferred embodiment and as depicted in FIGS. 2 and 3,includes wire member 42. Wire member 42 extends from the proximal end tothe distal end of the endoscopic device and preferably extend along thewalls of lumen 32, 34 and adjacent to endoscope 30. Wire member 42 hasan elastic memory that aids in the deflection of the walls of lumen 32,34. The elastic memory of wire member 42 is impeded by the rigidity ofendoscope 30, and/or covering 29 and slots 31. such that the distal endof wire member 42 returns to its elastic memory only when extendedbeyond the distal end of endoscope 30, and/or covering 29 and slots 31.Preferably, wire member 42 is formed of nitinol, spring steel, or othersuitable material of similar elastic characteristics. Wire member 42 isalso preferably flat or oval shaped, however, other shaped structuresare within the scope of the invention.

[0048] Wire member 42 is contained inside a tubular member 43 thatextends along the outside of lumen 32, 34 and adjacent endoscope 30, asshown in FIG. 3. Tubular member 43 is fixedly disposed to the outside oflumens 32, 34 and extends from the proximal end to the distal end of thelumen. The distal end of tubular member 43 is sealed so that wire member42 cannot extend beyond the confines of tubular member 43. The proximalend of tubular member 43, however, is open to permit the proximal endmanipulation of wire member 42.

[0049] As previously discussed, at the time of endoscope insertion, thedistal end of the endoscopic device remains substantially flat, i.e. ina single plane. Once arriving at the operation site, lumen 32, 34 isextended beyond endoscope tip 40. Once lumens 32, 34 are positioned, asdesired, wire member 42 is advanced beyond endoscope tip 40 to createthe desired distal end deflection. To move wire member 42 within tubularmember 43, the operator advances or retracts wire member 42 at theproximal end. This proximal end manipulation causes wire member 42 tomove in relation to tubular member 43. To enhance the movement of wiremember 42 within tubular member 43, the interior of tubular member 43preferably possesses a lubricious coating or resin, such as teflon,polypropylene, or nylon. As wire member 42 extends beyond endoscope tip40, the distal end of wire member 42 returns to its elastic memory. Thisdistal end deflection of wire member 42 causes tubular member 43 todeflect, which, in turn, causes deflection of the distal end of thelumen 32, 34 to which it connects. The endoscope operator may controlthe degree of distal end deflection of lumen 32, 34 by varying thedistance that wire member 42 and/or lumen 32, 34 extend beyond endoscopetip 40.

[0050] Alternatively, wire member 42 may extend beyond endoscope tip 40simultaneously with the advancement of lumen 32, 34. For example, wiremember 42 may be fixedly fastened to the walls of lumen 32, 34 (withoutthe provision of a tubular member) or may be fixedly fastened to tubularmember 43 itself. In such cases, the distal end of wire member 42, asfixedly fastened proximate to the distal end of a lumen 32, 34,possesses no independent mobility, and the extension of wire member 42beyond endoscope tip 40 depends upon the extension of its correspondinglumen 32, 34 beyond endoscope tip 40. To create the desired distal enddeflection, lumens 32, 34 are extended beyond endoscope tip 40. As thedistal end of lumen 32, 34 and wire member 42 protrude beyond endoscopetip 40, the distal end of wire member 42 extending beyond endoscope tip40 returns to its natural deflected state due to its elastic memory.This deflection, in turn, causes lumen 32, 34 to deflect. To control thedegree of distal end deflection of lumen 32, 34, the endoscope operatormay vary the distance that lumen 32,34 extend beyond endoscope tip 40.

[0051] Regardless of whether wire member 42 extends simultaneously withlumen 32, 34 or independently of lumen 32, 34, once wire member 42extends beyond endoscope tip 40, wire member 42 returns to its naturallycurved position. The distal end curvature of wire member 42 causes lumen32, 34 to deflect. Because wire member 42 possesses an elastic memorywith a stiffness insufficient to bend endoscope 30, wire member 42returns to its elastic memory only after advancing beyond endoscope tip40. Once wire member 42 extends beyond endoscope tip 40, the distal endof lumen 32, 34 deflects in response to the curvature of wire member 42.

[0052] Although the drawings depict only one wire member per lumen,multiple wire members may be used to controllably deflect a particularlumen. Additional wire members dispersed along the walls of the lumenoffer enhanced control over the direction and deflection of the lumen.For example, by positioning the wire members along various points on theperimeter of the lumen, each wire member may control a differentdirection of deflection. The additional wire members, as positioned,give the operator the ability to deflect the distal end of the lumen ina multitude of directions.

[0053] In a second preferred embodiment of the present invention, asshown in FIGS. 4 & 5, a controllable endoscopic sheath 128 includes anactuator having a stiffening member 50, 51. In addition, each lumen 53,54 includes a deflectable lumen tip 52 having an elastic memory.Stiffening members 50, 51 extend from a proximal end to a distal end ofendoscope 30 and possess distal end rigidity sufficient to impede onlythe elastic memory of lumen tip 52. Stiffening member 50, 51 may beformed of either silicon, urethane, expanded teflon, or other suitablematerial having sufficient rigidity.

[0054] Each stiffening member 50, 51 preferably resides inside a tubularmember 56, 58 that is disposed along the outside of lumen 52, 54 andpositioned adjacent to endoscope 30, as shown in FIG. 5. Tubular member56, 58 is fixedly disposed to the outside of lumen 52, 54 and extendsfrom the proximal end to the distal end of the lumen. The distal end oftubular member 56, 58 is sealed so that stiffening member 50, 51 cannotextend beyond the confines of tubular member 56, 58. The proximal end oftubular member 56, 58, however, is open to permit the proximal endmanipulation of stiffening member 50, 51.

[0055] Similar to the previous embodiment, the endoscopic device entersand passes through a body cavity of the patient while the device has asubstantially flat distal end. In other words, each of endoscope 30,sheath 128, and its lumen 53, 54 terminate at about the same distalplane. As configured, the endoscopic device traverses the body cavityuntil the distal end of endoscope 30 arrives at the operation site. Tocreate the desired distal end deflection, lumens 53, 54 are firstextended beyond endoscope tip 40. Once beyond endoscope tip 40, theelastic memory of tip 52 of lumen 53, 54 causes the distal end of lumen53, 54 to deflect to their natural deflected state. To impede thisdeflection and control the curvature of the distal end of lumen 53, 54,stiffening member 50, 51 is extended within tubular members 56, 58 to apoint beyond endoscope tip 40. The operator may control the degree ofdistal end deflection of lumen 53, 54 by varying the distance that thelumen 53, 54 and/or stiffening member 50, 51 extends beyond endoscopetip 40.

[0056] To move stiffening member 50, 51 within tubular member 56, 58,the operator advances or retracts stiffening member 50, 51 at theproximal end. This proximal end manipulation causes stiffening member50, 51 to move in relation to tubular member 56, 58. To enhance themovement of stiffening member 50, 51, the interior of tubular member 56,58 preferably possesses a lubricious coating or resin, such as teflon,polypropylene, or nylon. As a stiffening member 50, 51 extends beyondendoscope tip 40, the distal end of stiffening member 50, 51 impedes thedeflection of tip 52 of the corresponding lumen 53, 54.

[0057] Accordingly, the amount of lumen deflection can be controlled bylimiting the deflection of tip 52 of lumen 53, 54 by extendingstiffening member 50, 51 beyond endoscope tip 40. In contrast to thefirst embodiment, where advancement of wire member 42 enhances thedistal end deflection, advancing stiffening member 50, 51 beyondendoscope tip 40 hinders the elastic deflection of tip 52, thus,limiting the deflection of lumen 53, 54.

[0058] Although the drawings depict only one stiffening member perlumen, multiple stiffening members may be used to controllably deflect aparticular lumen. Additional stiffening members dispersed along thewalls of the lumen offer enhanced control over the direction anddeflection of the lumen. For example, by positioning the stiffeningmembers along various points on the perimeter of the lumen, eachstiffening member may control a different direction of deflection. Theadditional stiffening members, as positioned, give the operator theability to deflect the distal end of the lumen in a multitude ofdirections.

[0059] In a variation of the second preferred embodiment, a stiffeningmember may be fixedly disposed to the outside of endoscope 30 andadjacent to lumen 53, 54. As disposed, the distal end of the stiffeningmember extends along the distal end of endoscope 30 and possessessufficient rigidity to impede the elastic memory of lumen tip 52. Tocreate the desired distal end deflection, lumens 53, 54 are extendedbeyond endoscope tip 40, as previously described. As the distal end oflumen 53, 54 extends beyond endoscope top 40, the elastic memory of tip52 causes the distal end of lumen 53, 54 to deflect. To control thedegree of distal end deflection of lumen 53, 54, the endoscope operatormay vary the distance lumen 53, 54 extends beyond endoscope tip 40 bymanipulating the proximal end of lumen 53, 54.

[0060] As an example of this variation of the second embodiment and asshown in FIGS. 6 and 6A. a stiffening member may include sheath guide60, 61 fixedly disposed to the outside of endoscope 30 and adjacent tolumen 53, 54. As best shown in FIG. 6A, sheath guide 60, 61 isconfigured to engage with guide pin 64, 65. Guide pin 64, 65 is fixedlydisposed along the walls of lumen 53, 54 and adjacent to endoscope 30.Once again, the distal end of sheath guide 60, 61 possesses sufficientrigidity to impede the deflection of the distal end of lumen 53, 54.

[0061] To create the desired distal end deflection, lumen 53, 54 extendsbeyond endoscope tip 40, as previously described. As the distal end oflumen 53, 54 extends beyond endoscope tip 40, the distal end of guidepin 64, 65 no longer communicates with sheath guide 60, 61. As such. thedeflection of tip 52 due to its elastic memory is no longer impeded bysheath guide 60, 61, and the distal end of lumen 53, 54 elasticallydeflects. Accordingly, the endoscope operator may control the degree ofdistal end deflection of lumen 53, 54 by regulating how far the distalend of guide pin 64, 65 (and lumen 53, 54 to which it is attached)extends beyond endoscope tip 40 and sheath guide 60, 61.

[0062] In a third preferred embodiment of the present invention, acontrollable endoscopic sheath 228 includes an actuator having aflexible extension. The flexible extension eccentrically attaches to aflexible elongated member. This third embodiment of an endoscopic sheathaccording to the present invention is illustrated in FIGS. 7-12.Preferably, the flexible elongated member includes cable 70, 72, theflexible extension includes spherical mating members 74, 76, 78, andsheath 228 includes an outer sheath 82 and a inner sheath 80. Sphericalmembers 74, 76, 78 are preferably constructed of a stainless steel orplastic material.

[0063] Each cable 70, 72 extends from the proximal end of itscorresponding lumen 153, 154 to the distal end, where it eccentricallyextends along corresponding spherical mating members 74, 76, 78positioned at the distal end of lumen 153, 154. As illustrated in FIG.9, preferably, cable 72 eccentrically extends through each of thespherical mating members 74, 76, 78, but cable 72 may alternativelytraverse along the exterior of each of spherical mating members 74, 76,78.

[0064] To prevent the distal end of cable 72 from proximally retractingbeyond the distal-most spherical mating member 78, the distal end ofcable 72 includes a stop 85, as shown in FIGS. 9, 11, and 12. Stop 85may be a sphere, or similar structure, having a surface area larger thanthat of the passage traversed by cable 72. As configured, stop 85impedes the proximal retraction of cable 72 beyond the most distal endspherical mating member 78, because stop 85 restrictively engages thedistal end of the cable passage.

[0065] Preferably, stop 85 securely fastens to the distal end of cable72. For example, stop 85 may include a hollow interior that serves as achannel for receiving the distal end of cable 72. As configured, theexterior of the distal end of cable 72 and the interior of stop 85include complementary threaded surfaces that permit the secure fasteningof stop 85 on the distal end of cable 72. Alternatively, cable 72 may beconstructed to permanently include at its distal end stop 85. Regardlessof the particular construction, stop 85 impedes the proximal retractionof cable 72 beyond the most distal end spherical mating member 78.

[0066] As depicted in FIGS. 9, 11, and 12, spherical mating members 74,76, 78 preferably reside within the interior distal portion of outersheath 82. As disposed, spherical mating members 74, 76, 78 encompassand define the distal end portion of lumen 153, 154, while the remainingportion of lumen 153, 154 is encompassed and defined by inner sheath 80,which extends from the proximal end of lumen 153, 154 to a pointproximate to the distal end of lumen 153, 154. The distal end of innersheath 80 attaches to the most proximal spherical mating member 74 toensure the continuity of lumen 153, 154 from the proximal end to thedistal end of outer sheath 82. To permit the travel of surgicalinstruments through the distal end of lumen 153, 154, spherical matingmembers 74, 76, 78 include a hollow center passage 89 (see FIGS. 13-15)substantially equal to the inner surface dimensions of inner sheath 80.Accordingly, the working channel of lumen 153, 154 is defined by theinner surface dimensions of inner sheath 80, and center passage 89 ofspherical mating members 74, 76, 78. To ensure the unhamperedunobstructed passage of surgical instruments, spherical mating members74, 76, 78 are preferably constructed of a stainless steel or plasticmaterial.

[0067] As illustrated in FIG. 13, each of spherical mating members 74,76, 78 includes a male end 75 and a female receiving end 77. Male end 75and female receiving end 77 complement one another in configuration. Inparticular, the outer surface dimensions of male end 75 closelycorrespond to the inner surface dimensions of female receiving end 77.As depicted in FIG. 13, end 75 includes a spherical shape of a diametercomplimentary in size to the cone shaped opening of receiving end 77.This complementary configuration facilitates a secure attachment betweenrespective male end 75 and female receiving end 77 of adjoiningspherical mating members 74, 76, 78. To attach the respective ends ofthe spherical mating members, end 75 is forced into receiving end 77.The amount of outer surface area of end 75 encompassed by the interiorof receiving end 77 depends upon the amount of force used in insertingend 75 into receiving end 77. Typically, the greater the force, the morereceiving end 77 encompasses end 75, and vice versa. Once attached, toprevent adjoining spherical mating members 74, 76, 78 fromuncontrollably separating from one another, female receiving end 77includes a rounded end 99 that encircles a portion of attached male end75.

[0068] Preferably, each of spherical mating members 74, 76, 78 alsoincludes a slot 79 and an index tab 81. Slot 79 is disposed at femalereceiving end 77, while index tab 81 is disposed at male end 75. Theinteraction between slot 79 and index tab 81 enhances the attachmentbetween the spherical mating members and controls the flexibility of theadjoining spherical mating members 74, 76, 78. As end 75 is insertedinto receiving end 77, slot 79 and index tab 81 are aligned so that slot79 may receive index tab 81. Depending upon the force exerted inattaching end 75 into receiving end 77, index tab 81 may rest withinslot 89 at an increased or decreased dept.

[0069] The degree of deflection of the adjoining spherical members isdirectly dependent upon the depth of index tab 81 in slot 79. Forexample, allowing index tab 81 to travel an increased slot depth allowsend 75 to delve deeper into receiving end 77, thus, providing adjoiningspherical mating members 74, 76, 78 with increased flexibility.Alternatively, a decreased slot depth limits the penetration of male end75 into female receiving end 77, therefore, limiting the degree ofdeflection of adjoining spherical mating members 74, 76, 78. Dependingupon the requirements of the particular endoscopic procedure, the designof the spherical mating members permits the endoscope operator to varyits flexibility accordingly by altering the depth of index tab 81 inslot 79.

[0070]FIG. 9 shows features of the distal end of lumen 154 andcorresponding structure. Preferably, lumen 153 and correspondingstructural elements are similarly arranged. As illustrated in FIG. 9.lumen 154, spherical mating members 74, 76, 78, and cable 72 preferablyexist in two separate sheaths. The first sheath, an inner sheath 80,extends from the proximal end of the endoscope to a point proximate tothe distal end of the endoscope. The distal end of inner sheath 80terminates at spherical mating members 74, 76, 78 and preferablyattaches to the most proximal end spherical member 74. Lumen 154 istherefore defined by the interior of inner sheath 80 and central passage89 of spherical mating members 74, 76, 78. The proximal and distal endsof inner sheath 80 and central passages 89 are open to permit theunimpeded movement of surgical instruments through the interior of lumen154.

[0071] As illustrated in FIG. 9, cable 72 preferably extends along theexterior of inner sheath 80. Cable 72, however, may also extend withinthe walls of inner sheath 80 or along the interior of sheath 80. Thesecond sheath, an outer sheath 82, houses spherical mating members 74,76, 78, cable 72, inner sheath 80, and lumen 154. Outer sheath 82 isfixedly disposed along the exterior of endoscope 30 and extends from theproximal end to the distal end of endoscope 30. As disposed, outersheath 82 acts as a slot of sheath 228 in that it permits the movementof inner sheath 80, spherical members 74, 76, 78, cable 72, and lumen154 in relation to endoscope 30. The distal end of outer sheath 82 isopen to permit inner sheath 80, spherical members 74, 76, 78, cable 72,and lumen 154 to extend beyond endoscope tip 40. The proximal end ofouter sheath 82 is similarly open to permit the proximal endmanipulation of cable 72 and inner sheath 80.

[0072] Similar to the previous embodiments and as depicted in FIGS. 7and 9, the endoscopic device traverses the cavities of the body with asubstantially flat distal end, where each of the endoscope and sheath,with its lumens, distally terminate at about the same plane. Oncearriving at the operation site, the endoscope operator extends one ormore lumens 153, 154 beyond endoscope tip 40 and proximate to theoperation site by manipulating the proximal end of the endoscopicdevice.

[0073] To extend lumen 153, 154, the proximal end of inner sheath 80 isadvanced by the endoscope operator towards the operation site. Toenhance the movement of inner sheath 80 within outer sheath 82, theinterior of outer sheath 82 and/or the exterior of inner sheath 80 arepreferably composed of a lubricious material, such as teflon,polypropylene, or nylon. Because lumen 153, 154 is defined by theinterior of inner sheath 80 and attached central passage 89, theproximal end movement of inner sheath 80 corresponds to a similar distalend movement of lumen 153, 154. As mentioned, the distal end of innersheath 80 terminates at and is attached to the most proximal endspherical mating member 74. Thus, as the proximal end of inner sheath 80is advanced towards the operation site, the distal end of inner sheath80 similarly advances spherical mating members 74, 76, 78. Theadvancement of spherical mating members 74, 76, 78 as well as theattachment of the most proximal end spherical member to the distal endof lumen 154 ensure a distal advancement of inner sheath 80 thatcorresponds to the proximal advancement of inner sheath 80.

[0074] After lumen 153, 154 is advanced, as desired, the endoscopeoperator manipulates the proximal end of cable 70, 72 to create thenecessary distal end deflection of lumen 153, 154. At the time ofinsertion, spherical mating members 74, 76, 78 are loosely oriented withrespect to one another, as shown in FIG. 9. In other words, the distalend of cable 70, 72 provides insufficient tension to cause sphericalmating members 74, 76, 78 to forcefully abut. As the endoscope operatorretracts the proximal end of cables 70, 72, the corresponding length ofcable 70, 72 connected to spherical mating members 74, 76, 78 shortens.The shortening of this cable length causes the distal end of cable 70,72 to proximally retract along spherical mating members 74, 76, 78 untilstop 85 engages the most distal end spherical mating member 74. At thisparticular point, the tension in cable 70, 72 causes spherical matingmembers 74, 76, 78 to forcefully abut one another. Because sphericalmating members 74, 76, 78 are tightly aligned with respect to oneanother and stop 85 prevents cable 72 from retracting through sphericalmembers 74, continual proximal end retraction of cable 72 causes a bendin the alignment of spherical members 74, 76, 78, as shown in FIG. 12.The distal end of lumen 154, which corresponds to central passage 89 ofspherical members 74, 76, 78, deflects in response to the bent alignmentof the spherical mating members. To control the amount of distal enddeflection of lumens 153, 154, the endoscope operator may vary theretraction of cable 70, 72 in the proximate direction to control amountof bend imposed on spherical mating members 74, 76, 78.

[0075] Although the drawings depict only one cable and there sphericalmembers per lumen, additional cables may be eccentrically positionedalong the respective spherical members to offer enhanced control overthe direction of the distal end deflection of the lumen. Theseadditional cables give the operator the ability to deflect the distalend of the lumen in a multitude of directions, because each cable, aseccentrically positioned along the spherical members, may control adifferent direction of deflection. In addition, more or less than threespherical members may be used to provide more or less precision in thedegree of distal end deflection of the lumen.

[0076] It will be apparent to those skilled in the art that variousmodifications and variations can be made in the endoscopic device of thepresent invention and in construction of this endoscopic device withoutdeparting from the scope or spirit of the invention.

[0077] Other embodiments of the invention will be apparent to thoseskilled in the art from consideration of the specification and practiceof the invention disclosed herein. It is intended that the specificationand examples be considered as exemplary only, with a true scope andspirit of the invention being indicated by the following claims.

What is claimed is
 1. A sheath apparatus for use with an endoscope, thesheath apparatus comprising: a flexible elongated sheath for surroundingan endoscope, the sheath having a flexible lumen extending within thesheath and adjacent to the endoscope so as to permit the lumen to movein relation to the endoscope and beyond a distal tip of the endoscope,the lumen having a deflectable distal end; and a controller devicecoupled to the flexible lumen for controlling deflection of the distalend of the lumen.
 2. The apparatus according to claim 1, wherein thecontroller device is connected to the distal end of the lumen forcontrolling deflection of the distal end of the lumen.
 3. The apparatusaccording to claim 1, wherein the flexible lumen is configured to allowthe delivery of surgical tools to an operating site.
 4. The apparatusaccording to claim 2, wherein said controller device includes a wiremember disposed on the flexible lumen, the wire member having a naturaldeflected state and an elastic memory that returns the wire member tothe natural deflected state as the wire member extends beyond the distaltip of the endoscope.
 5. The apparatus according to claim 4, whereinsaid controller device includes a second lumen containing the wiremember, the second lumen disposed along the walls of the flexible lumen,whereby the wire member moves in relation to the second lumen.
 6. Theapparatus according to claim 4, wherein said wire member is formed ofone of nitinol and spring steel.
 7. The apparatus according to claim 2,wherein said controller device includes a stiffening member disposedalong the outside of the lumen and adjacent to the endoscope, andwherein a distal tip of the lumen has a natural deflected state and anelastic memory that returns the distal tip to the natural deflectedstate as the lumen extends beyond the stiffening member and the distaltip of the endoscope.
 8. The apparatus according to claim 7, whereinsaid controller device includes a second lumen containing the stiffeningmember, the second lumen disposed along the walls of the flexible lumen,whereby the stiffening member moves in relation to the second lumen. 9.The apparatus according to claim 7, wherein said stiffening member is asheath guide disposed along the exterior of the endoscope and adjacentto the lumen, and wherein the lumen includes a guide pin disposed alongthe exterior of the lumen and adjacent to the endoscope, the sheathguide engaging the guide pin.
 10. The apparatus according to claim 2,wherein said controller device includes a flexible elongated memberextending from the proximal end to the distal end of the lumen, theflexible elongated member being eccentrically attached to the lumen,where retraction of the elongated member in the proximal directiondeflects the distal end of the lumen.
 11. The apparatus according toclaim 10, wherein said elongated member is a cable.
 12. The apparatusaccording to claim 11, further comprising a plurality of sphericalmating members extending within the distal end of the sheath, each ofthe plurality of spherical mating members including a centralpassageway, where the distal end of the lumen is encompassed and definedby the central passageway.
 13. The apparatus according to claim 1,wherein the sheath is comprised of one of braid, latex, polypropylene,and polyurethane.
 14. The apparatus according to claim 1, where one ofan exterior surface of the lumen and a corresponding interior surface ofthe sheath includes a lubricious material for enhancing movement of thelumen in relation to the sheath.
 15. The apparatus according to claim 1,further comprising a plurality of flexible lumens extending within thesheath and adjacent the endoscope.
 16. The apparatus according to claim15, wherein the plurality of flexible lumens includes two flexiblelumens positioned on opposite sides of the endoscope.
 17. The apparatusaccording to claim 1, wherein said lumen is comprised of a flexibleplastic material.
 18. The apparatus according to claim 17, wherein saidflexible plastic material is of one of teflon, polypropylene,polytetrafluoroethylene, tetrafluoroethylene, and nylon.
 19. Anendoscopic device comprising: an endoscope; a flexible elongated sheathfor surrounding the endoscope, the sheath having a flexible lumenextending within the sheath and adjacent to the endoscope, the lumenextendible beyond a distal tip of the endoscope and having a deflectabledistal end; and a controller device coupled to the flexible lumen forcontrolling deflection of the distal end of the lumen.
 20. A method forusing an endoscopic device in an endoscopic procedure, the endoscopicdevice including an endoscope, a flexible elongated sheath surroundingthe endoscope, and a flexible lumen extending within the sheath andadjacent to the endoscope for containing a surgical tool, the methodcomprising the steps of: inserting the endoscopic device into a bodycavity of a patient; maneuvering the endoscopic device through the bodycavity and proximate to an operation site; extending a distal end of thelumen beyond a distal tip of the endoscope; and deflecting the extendeddistal end of the lumen to maneuver the surgical tool.
 21. The method asrecited in claim 20, wherein the extending step includes advancing theproximal end of the lumen in the distal direction.
 22. The method asrecited in claim 20, wherein the endoscopic device includes a wiremember having an elastic memory and disposed adjacent to the lumen, andwherein the deflecting step includes extending the wire member beyondthe distal tip of the endoscope.
 23. The method as recited in claim 20,wherein the lumen has a natural deflected state and an elastic memory atthe distal end, and wherein the deflecting step includes extending astiffening member beyond the distal tip of the endoscope, the stiffeningmember impeding the distal end of the lumen from retaining the naturaldeflected state.
 24. The method as recited in claim 20, wherein thelumen has an elongated member extending along the lumen andeccentrically attached to a flexible extension disposed on the lumen ata distal end, and wherein the deflecting step includes retracting theelongated member in a proximal direction deflect the flexible extension.